Commission clarifies its position on registration obligations regarding cease of manufacturing before the 2018 deadline

Date: 27 April 2018

In SCC’s last newsletter we reported about the Commission’s position on phase-in status after May 2018 with a special focus on Commission’s interpretation of registration obligations.

On 4 April, the Commission provided a clarification on its statement. The intention of the statement was to confirm that, regardless of whether a manufacturer or importer of a phase-in substance ceases to manufacture or import after the deadline, he will have to register. This differs from the scenario described by the Germany CA which focuses more on the scenario before the registration deadline.

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Consequently the commission modified the wording of its statement as follows:
“[…] the Commission wishes to clarify that if a manufacturer or importer of a phase-in substance, who has pre-registered that substance, exceeds the 1 tonne per year threshold in 2018, based on the 'three-year average' rule in Article 3(30), but has ceased the manufacture or import of that substance before the final registration deadline on 1 June 2018, then he will not be required to register after the deadline has passed unless he subsequently restarts the manufacture or import of the substance and the conditions of Article 6 of REACH are met.”

Taking this updated statement into account the Commission’s interpretation is in-line with the interpretation of the national helpdesk, ECHA’s F&Q and the ECHA guidance documents.

We would like to point out that one should closely monitor the manufacturing / import of substances until the deadline in order to ensure that no import or manufacturing takes place after 31 May 2018 which results in an overall tonnage above 1 tpa. Please keep in mind that the time point for import is the arrival of the shipment at the European customs clearance.
In case you have any questions or need further support, please get into This email address is being protected from spambots. You need JavaScript enabled to view it. with us.

Dr Thomas Roth, Head of Chemicals/REACH, Consumer Products, Cosmetics, Feed & Food Additives
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EPA Interim Science Policy for the Replacement of Animal Testing for Skin Sensitisation

Date: 27 April 2018

On 10 April 2018, EPA published a draft of an Interim Science Policy to reduce animal testing for skin sensitization, which can be found here. The draft of the Interim Science Policy is open for public comment until June 9, 2018.

The draft document states that the Office of Pesticide Programs (OPP) and Office of Pollution Prevention and Toxics (OPPT) will immediately begin to accept submissions as described in the draft Science Policy.

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It lists OECD test guidelines that will be accepted in submissions to the Agency for single chemicals. For the time being, alternative testing will be accepted only for pesticide active and inert ingredients, but not yet for formulations. However, the agency states that it expects expansion of this interim policy in the near term to include some pesticide formulations or other mixtures evaluated by OPPT.

In contrary to the situation in Europe where a clear guidance for the regulatory interpretation of the alternative method is still pending, EPA has defined clear criteria how the results of the alternative test methods should be handled.

The two following defined approaches (DA) will be accepted by EPAs as alternatives to the LLNA for regulatory submission:

  • Adverse Outcome Pathway (AOP) “2 out of 3”
  • Key events (KE) 3/1 sequential testing strategy (STS)

The first DA was initially submitted to OECD by BASF and reflects the current approach used for the non-animal test strategy in the scope of EU REACH (SCC Comment: The “2 out of 3” approach is not yet officially confirmed by ECHA): At least two studies need to be conducted in order to assess two different key events. If these studies provide discordant results, a study for a third key event needs to be performed. The overall result is based on the two concordant findings. In case two positive findings are revealed this leads to a conclusion as sensitizer.

The second DA reflects a simple decision tree that requires only two studies. The first study investigates the key event 3 (Dendritic cells). If the response is positive, the test substance is classified as a sensitizer. If a negative result is obtained from a key event 3 assay, an assay for key event 1 (covalent interaction with skin proteins) is conducted. A negative study for key event 1 confirms that it is a non-sensitizer and a positive result for key event 1 leads to a finding of sensitizer.

A project proposal was submitted to OECD jointly by the US, EU, and Canada to develop a new performance-based test guideline (PBTG) for defined approaches for skin sensitization. As part of the work on the future OECD PBTG guideline, refinements and updates to some of the defined approaches are expected in the near-term (until end of Q4 2018).

SCC's conclusion is as follows: In case companies already generated data for skin sensitisation for chemicals subjected to registration under REACH using the “2 out of 3”, these data will be accepted by EPA and thus additional animal studies do not need to be conducted in order to comply with US data requirements in the near future.

Dr Thomas Roth, Head of Chemicals/REACH, Consumer Products, Cosmetics, Feed & Food Additives
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